An Evaluation of Maternal Position During Cesarean Delivery

Cesarean Section Clinical Trial

Official title:

A Randomized Controlled Trial Evaluating Maternal Tilt During Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02872181
• Other study ID #: HartfordH
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2020

Study information

• Verified date: July 2018
• Source: Hartford Hospital
• Contact: adam sachs, MD
• Phone: 860-972-2117
• Email: asachs29[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

During Cesarean Delivery pregnant women are frequently tilted to the left 15 degress to reduce compression of the major blood vessels by the uterus. Despite this common practice, there is no conclusive evidence to support this practice. In fact it may even be deleterious to have women positioned in this position. The aim of the study is to determine whether or not tilting women to the left during cesarean section (CS) is helpful or detrimental. The authors hypothesize that left uterine displacement of 15 degrees, which is commonly employed, is useless for preventing compression of these blood vessels. To investigate this question, women will be randomly assigned to either be tilted 15 degrees to the left during CS or positioned flat on the table. Fetal acid base status, vasopressor/phenylephrine use, patient satisfaction, maternal complications, and fetal complications will all be collected and compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• term pregnant women with an uncomplicated pregnancy course undergoing scheduled cesarean delivery

• =18 years old

• ASA 1 and 2 (i.e., patient is completely healthy (1) or has mild systemic disease (2)

• Able and willing to consent to participate

Exclusion Criteria:

• Males

• <18 years old

• maternal cardiac/pulmonary/hematologic disorders/renal failure

• drug/alcohol/tobacco use during pregnancy

• essential or pregnancy-induced hypertension

• diabetes greater than 10 years

• pre-eclampsia or abruptio placenta

• <37 weeks gestation

• hemoglobin < 7 g/dL

• intrauterine growth retardation

• fetal distress or fetal anomaly

• Transverse lie

• Ruptured membranes

• Severe polyhydramnios or oligohydramnios

• Multiple gestation

• severe scoliosis or kyphosis,

• uterine abnormalities (e.g., large fibroids, bicornuate uterus)

• Failed spinal (sensory level < T6 after 15 minutes)

• need to convert to general anesthesia before delivery

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Procedure:
• Supine
Placed in Supine position
• Left uterine displacement
Placed in 15 degrees left uterine displacement

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neonatal base deficit from uterine artery immediately after cesarean delivery of the fetus		One data point will be used. The neonatal gas from the uterine artery immediately after delivery
Secondary	total phenylephrine use in micrograms prior to delivery		The aggregate of the phenylephrine used immediately after spinal (total of 20 minutes) or until delivery of the baby
Secondary	APGAR scores of the newborn as assessed by the neonatologist immediately after cesarean delivery		1 and 5 minute apgar scores of the newborn fetus will be compared